Does that title sound wrong? Backwards maybe? Is this really an article about CDMOs having a client checklist?
Yes, it is.
Numerous articles have been written from the perspective of clients having a checklist when choosing a CDMO, and while reading a recent one from Stephanie Gaulding from PharmaTech Associates (a very informative piece!), it occurred to me that while these lists are useful – they miss the full story. In order for a sponsor to get everything out of the CDMO that they want and need, they also should remember that it is a two-way relationship. This three-part series delves into some of these issues to inform sponsors what the CDMO needs for a fruitful win-win relationship. The key factors will sound similar to the CDMO checklist that clients use, which shouldn’t be surprising.
By far, the most important ingredient to a successful CDMO-client relationship is transparency. Just as a client wants a transparent CDMO, the CDMO also desires a transparent client. As a client, how you manage the project, how you view the CDMO’s expertise and decision making, and your priorities when negotiating contracts are all factors a CDMO considers when taking on new sponsors. Each of these actions and behaviors set the tone for the client/CDMO relationship. Handling them in the proper manner is key in building a relationship based on trust and transparency. Let’s get into it.
Transparency
In real estate they say location, location, location. For the CMDO/client relationship: transparency, transparency, transparency. Should a CDMO be transparent? Absolutely! But does the sponsor need to be transparent as well? Also yes! This is one area that is often seen as one-way; sponsors expect the CDMO to be fully transparent, yet they do not want to reciprocate. That doesn’t mean the sponsor needs to reveal all of their trade secrets and strategies to their CDMO. Instead, here is a list that covers crucial areas where sponsor transparency is essential.
Process Robustness
One of the major items that leads to CDMO/Client tension is a misalignment on the process’ actual capability at the time of tech transfer. I have seen a number of times when the sponsor described their process as robust, reproducible, and ‘locked-down’, only to find out the process had only been run at small scale four times with three different permutations, with two of the runs providing passable data, while two failed miserably.
When entering into what both sides hope is a long-term relationship, start with an honest assessment of how developed the process truly is. While it is the CDMO’s responsibility to ask the right questions, it is also the sponsor’s obligation to answer them honestly and in full. Don’t waste valuable time trying to make your process sound better than it is, because sooner or later the CDMO’s process experts will uncover the actual state of the process. When preparing to talk to a CDMO, think about how you should best summarize what you will tech transfer. Here is a short list of what a CDMO finds helpful:
Is the process currently being run at full-scale, or at something less than full-scale?
If it is routinely run at small scale, have you ever run at what you think full-scale will be?
How many times have you run the process?
Does this number include multiple iterations of a baseline process? If you have run the process 20 times in 20 different ways, the answer of “20” is misleading. The CDMO needs to know how many times you have run it with the exact process you plan to tech transfer.
How consistent are your results?
Often there is insufficient data for a true statistical review, so share the raw data. Are you seeing a CV under 20% for the three runs you have done, or are seeing one of 80%? Even with a small n, the variability in the data is crucial to understanding how much development might be required.
Have you ever run this process with a patient sample?
The answer is usually no (and that is ok!), but if you did and it failed while donor material succeeded, this should be disclosed and discussed.
What do you understand of donor/sample variability?
Did you run the process 10 times but all from the same apheresis, or have you run 10 different donors? Do you have any screening criteria you have developed (or started to develop) that will help you select patients or donors more likely to succeed in manufacturing? During the tech transfer and GMP qualification process you are likely to see the CDMO request a significant number of runs/replicates. This is not only for operator training, documentation preparation, and so on, but especially in an autologous setting, this also helps the CDMO understand sample variability. If you have existing data on this, make sure to share it with the CDMO. A robust data set may allow the CDMO to reduce the number of runs (and, hence, reduce the sponsor’s cost).
Read the next parts of the Checklist Series: